Response to preoperative concomitant radiochemotherapy with mitomycin C and 5-fluorouracil in advanced head and neck...

Advanced head and neck tumours have a poor prognosis due to the high frequency of local recurrence. Multimodality treatment has been shown to be effective in decreasing local recurrence. In this study, 51 patients with advanced oral and oropharyngeal carcinoma were entered in a trial of preoperative radio-chemotherapy. After exclusion of -10 protocol violations (no surgery or no chemotherapy), 41 patients remained evaluable. Chemotherapy consisted of 15 mg mitomycin C/m2 given intravenously (bolus) on day 1. 5-Fluorouracil (750 mg/m2/24 h) was infused during days 1-5 (continuous infusion for 120 h). Radiotherapy was performed simultaneously with chemotherapy beginning on day 1. A total dose of 50 Gy to the primary tumour and neck region was delivered over 5 weeks. Treatment was well tolerated. Side-effects were mainly of local character (mucositis). No severe systemic toxicity was seen. Some delayed wound healing was noted at the operation (4 weeks after irradiation). The CR rate of the primary tumours was 56% (23/41). In 39% (16/41) only histological residual tumour was found. Two patients had minor response (categorized as NR) of their tumour (macroscopic residual tumour). None had tumour progression. The response rates considering lymph node metastases were 59% (22/37) CR, 35% (13/37) PR and 5% (2/37) NR. After a follow up of 18-30 months, analysis of local recurrent disease and survival was performed. The loco-regional recurrence rate was 32% (13/41) and the survival rate 63% (26/41). All deceased patients, except two, died of tumour progression. Patients with T4 tumours showed inferior prognosis whereas no significant difference in survival of T2 and T3 patients was found. Patients with CR of tumour and lymph nodes (including NO) have all survived and are without evidence of disease.